However fantastic your medical device or combination product, it will not get to market without appropriate evidence of your Human Factors work. Human Factors is now a regulatory requirement.
We conduct all our research according to the relevant ethical guidelines such as the MRS and BHBIA and when appropriate seek ethical approval.
We help you evidence your Human Factors work and support your regulatory submissions either as discrete tasks or full project support.
Example support includes:
- Task Analysis to understand all the discrete steps a user will take to interact with a device
- Comparative Threshold Analyses to identify whether any differences exist between a drug product already on the market and a new, similar drug product, instead of Human Factors testing
- Usability Risk Assessments to assess how a user’s perception, cognition and action is affected at each discrete task to identify foreseeable misuse scenarios.
- Identification of critical tasks for validation testing
- Support creating usability engineering file for regulatory submission
- Carrying out research on identification of known use issues
All our work is compliant and mindful of the relevant standards and guidelines including:
- AAMI/ANSI HE-75:2009 Human Factors Engineering – Design of Medical Devices
- IEC/BS EN 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
- IEC/BS EN 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
- UCM259760 ‘Applying Human Factors and Usability Engineering to Medical Devices’, FDA Guidance issued February 3rd 2016
- Guidance on applying human factors and usability engineering to medical devices including drug-device combination products, Version 2.0, MHRA Guidance issued January 2021
- ‘Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications’, FDA Draft Guidance issued October 2018
- ‘Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development’, FDA Draft Guidance issued February 2016
- Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry, FDA Draft Guidance issued July 2019
- ‘Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry’, FDA Draft Guidance issued January 2017
- ‘List of Highest Priority Devices for Human Factors Review’, FDA Draft Guidance issued February 2016
- ‘Guidance on the licensing of biosimilar products’, MHRA Guidance, issued May 2021